CAFC affirms invalidity through obviousness in Alza v. Mylan

In Alza v. Mylan, 2006 U.S. App. LEXIS 22616, the CAFC reviewed the district court's finding of invalidity through obviousness of the asserted claims of Alza's 6,124,355
patent but did not reach the invalidity through anticipation finding.

Of the law of obviousness, the CAFC wrote:

As for obviousness, a claimed invention is unpatentable if the
differences between it and the prior art are "such that the subject matter as a
whole would have been obvious at the time the invention was made to a person having
ordinary skill in the art." 35 U.S.C. § 103(a) (2000); In re Kahn, 441 F.3d 977,
985 (Fed. Cir. 2006) (citing Graham v. John Deere Co., 383 U.S. 1, 13-14,
86 S. Ct. 684, 15 L. Ed. 2d 545, (1966)). Obviousness is a question [*5] of law,
reviewed de novo, based upon underlying factual questions which are reviewed for
clear error following a bench trial. Ruiz v. A.B. Chance Co., 357 F.3d 1270,
1275 (Fed. Cir. 2004). These "underlying factual inquiries includ[e]: (1)
the scope and content of the prior art; (2) the level of ordinary skill in the
prior art; (3) the differences between the claimed invention and the prior art;
and (4) objective evidence of nonobviousness." In re Dembiczak, 175 F.3d 994,
998 (Fed. Cir. 1999). Similarly, "[t]he presence or absence of a motivation to
combine references in an obviousness determination is a pure question of fact,"
In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000); accord Winner Int'l
Royalty Corp. v. Wang, 202 F.3d 1340, 1348 (Fed. Cir. 2000), as is the presence
or absence of a "reasonable expectation of success" from making such a
combination, Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006).
Because "a patent retains its statutory presumption of validity, see 35 U.S.C. §
282, . . . the movant retains the burden to show the invalidity of the
claims by clear and convincing evidence as to underlying facts." McGinley v.
Franklin Sports, Inc., 262 F.3d 1339, 1349 (Fed. Cir. 2001) (internal quotations
omitted).

Of motivation, the CAFC wrote:

The Court of Appeals for the Federal Circuit's and its predecessor's
" motivation to combine" requirement likewise prevents statutorily
proscribed hindsight reasoning when determining the obviousness of an
invention. Kahn, 441 F.3d at 986 ("[T]he 'motivation-suggesting-teaching'
requirement protects against the entry of hindsight into the obviousness
analysis."); In re Fridolph, 30 CCPA 939, 942, 134 F.2d 414, 1943 Dec. Comm'r Pat. 350 (1943) ("[I]n considering more than one reference, the question always is: does
such art suggest doing the thing the [inventor] did."). According to the
"motivation -suggesting-teaching" test, a court must ask "whether a person of
ordinary skill in the art, possessed with the understandings and knowledge reflected
in the prior art, and motivated by the general problem facing the inventor,
would have been led to make the combination recited in the claims." Kahn, 441 F.3d
at 988 (citing Cross Med. Prods., Inc., v. Medtronic Sofamor Danek, Inc., 424
F.3d 1293, 1321-24 (Fed. Cir. 2005)).

As a general statement, the CAFC noted:

At its core, our anti-hindsight jurisprudence is a test that rests
on the unremarkable premise that legal determinations of obviousness, as with
such determinations generally, should be based on evidence rather than
on mere speculation or conjecture.

Discussing the specifics of this case, the CAFC observed:

As an initial matter, it is essential to recognize that, as we have
explained above, under our non-rigid "motivation-suggesting-teaching" test, a
suggestion to combine need not be found in the prior art. See Cross Med. Prods.,
424 F.3d at 1322 ("[T]he motivation to combine need not be found in prior art
references, but equally can be found in the knowledge generally available to one of
ordinary skill in the art . . . .").